Badrilla

Quality Assistance S.A. is a leading European Contract Research Organisation providing the pharmaceutical industry with all the analytical services required by EMA and FDA regulations for the development and marketing of innovative human medicinal products.

We assist our clients from candidate selection, through non-clinical and clinical studies, to marketing authorisation, using our state-of-the-art, product-dedicated expertise in analytical sciences.

For each customer and each project, we design customised solutions, define analytical protocols, develop and validate specific new analytical methods and perform characterisation, stability, pharmacokinetic, biomarker and immunogenicity studies as well as batch release testing, in order to evaluate the Quality, Safety and Efficacy of the given drugs.

Quality Assistance S.A. is an expert for the development of:
- Biologics (monoclonal antibodies, ADCs, proteins)
- New Chemical Entities, oligonucleotides, peptides
- Nanomedicine products
- Vaccines
- Cell-Based and Gene Therapy Medicinal Products

The company holds a unique position on the market with:
All its laboratories on one site (Donstiennes, Belgium)
- Bioanalysis (PK/TK/Immuno)
- Bioassays
- Biochemistry
- Chromatography
- Elemental Impurities
- Mass Spectrometry
- Microbiology
- Molecular Biology
- Protein Characterisation
200 highly qualified professionals
more than 35 years’ expertise at the forefront of analytical sciences.

Our core competencies are:
QUALITY (CMC)
- Development and validation of analytical methods
- Characterisation
- Stability studies
- Batch (release) testing
SAFETY/EFFICACY (Bioanalysis)
- Development and validation of bioanalytical methods
- PK/TK studies
- Immunogenicity studies
- Biomarker studies

The Quality Assistance environment is GMP, GLP and GCLP/GCP compliant.

Visit www.quality-assistance.com for more information

At Antibody Analytics we believe that scientists deserve the best data, and patients deserve the best drugs. Led by a group of talented and engaged scientists, we look at biological problems in an openminded way to deliver beautifully designed, developed and qualified bioassays.

We have developed a comprehensive portfolio of assays and platforms that can be tailored to support even the most complex of drug pipelines. Whether designing and developing bespoke bioassays or offering routine analysis on our already established assay platforms, Antibody Analytics has an exceptional track record of delivering beautiful results.

http://www.antibodyanalytics.com

Immunitrack provides a product and service pipeline to optimize immunogenicity assessments during drug development, as well as a broad portfolio of reagents to monitor patient CD8 and CD4 T cell responses to lead drug candidates during early R&D and clinical trials.

How Can Immunitrack Help R&D?
The Major Histocompatibility Complex (MHC) is critical to the immune response. Immunitrack has world-leading expertise in the manufacture and application of MHC I and II molecules to accurately study MHC epitope binding through our proprietary NeoScreen® platform.

Major Areas of Application
• Immuno-oncology: selection and study of neo-epitopes for personalized cancer vaccine development
• Vaccine development: selection of immunogenic epitopes from viral and bacterial targets
• Reducing immunogenicity of biologics: reduce the risk of anti-drug antibody development by identifying and removing CD4 T cell epitopes in candidate biologics.

Reagents
We produce customized MHC tetramers to detect and quantify subsets of patient immune (T) cells with specificity towards a given antigen within blood samples.

All of our MHC I reagents are produced on our optimized manufacturing platform, and we guarantee 100% peptide loading of each complex.

Binding Assays
Our unique NeoScreen® platform combines more than a decade of world-leading expertise in MHC/epitope binding assays with a high level of automation. The result is a highly scalable and accurate platform that can screen thousands of (neo-)epitopes.

Depending on the desired immune response our clients can then select and progress the best candidates through therapeutic development. Our repository is continuously growing, and currently holds more than 70 different MHC I and 20 MHC II alleles.

💡 A biotechnology group based on complementary expertise with multidisciplinary know-how

Custom Products & Services delivering a range of integrated biotechnology solutions 🤝

🏢 COMPANIES:

- RD-Biotech SAS (www.rd-biotech.com):
Custom services, Biomanufacturing and purification (monoclonal antibodies, recombinant proteins, plasmids, cells), hybridoma development, expression vectors, transfection, antibody sequencing, chimerization and humanization, analytical services and FastELISA kits for Immunoglobulins quantification and cellular contaminants detection.

- SYnAbs (www.synabs.be):
Primary and Secondary Antibodies Anti-species, Isotype controls, custom services, hybridoma development – rat, guinea pig, murine, Immunoassays

- QVQ (www.qvquality.com)
VHH Phage display services and a large range of VHH products

- Smaltis (www.smaltis.fr)
CRO specialized in microbiology, an high expertise in the fileds of antibiotic resistance, microbiota and strain engineering. Custom services and a large collection of genetically modified bacterial strains.

📈 EFFECTIVE SYNERGY

As part of a team of experts to ensure:
- The development of new biological tools in immunology, molecular biology, cellular engineering
- Identification of new markers
- The development of analytical methods
- Scientific and technical support
- The quality of services and products developed and manufactured in-house

✔ MAIN SECTORS OF ACTIVITY

- Pharmaceutical
- BioTherapeutics
- Biotechnology
- In vitro diagnostics
- Animal health
- Dermo-cosmetic
- Agribusiness
- Life sciences
- Environment
- Research Institutes

Anapharm Bioanalytics is a customer-focused bioanalytical CRO specialized in small and large molecule bioanalysis. Led by a team with over 30 years’ experience in method development, validation and sample analysis, we support drug development programs for the pharmaceutical, biotechnological and generic industries worldwide.

Equipped with state-of-the-art LC-MS/MS and LBA technology platforms, Anapharm Bioanalytics provides an array of services including PK studies, biomarker testing and immunogenicity assays throughout preclinical and clinical stages. Our global network of partners allows us to provide full-service outsourcing solutions to conduct preclinical, Phase I-IV clinical trials, and bioequivalence studies for international registration.

Our clients benefit from a deep scientific expertise combined with a robust quality system. All our activities are compliant with GLP and GCP, having undergone 20 regulatory inspections by the FDA, several EU Health Authorities and ANVISA (Brazil).

Whether your drug candidate is a new chemical entity, a new biologic, a generic or a biosimilar, do not hesitate to contact us at info@anapharmbioanalytics.com.